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The multigene HIV-1 plasmid DNA vaccine (HIVIS DNA) is an investigational DNA-based vaccine developed by the Swedish Institute for Infectious Disease Control (SMI), Karolinska Institutet, and Karolinska University Hospital. It is composed of seven plasmids encoding multiple HIV-1 antigens, including gp160 Env (subtypes A, B, and C), Rev (subtype B), Gag (subtypes A and B), and a mutated reverse transcriptase (RTmut, subtype B). This multigene, multiclade design is intended to elicit broad cellular (CD8+ T-cell) and humoral (antibody) immune responses against HIV-1. In clinical trials, such as the Phase I/II HIVIS 03 trial in Tanzania and the Phase I HVRRICANE trial in South Africa, it has been evaluated as a priming vaccine followed by boosting with recombinant Modified Vaccinia Ankara (MVA-CMDR) vector vaccines. The vaccine is typically administered intradermally using a needle-free injection device.
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